Senior Director, Oncology Medical Writing & Submissions

Page Mechanical Group, Inc.; Boston (MA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

AVEO Oncology in Boston seeks a Senior Director, Medical Writing to lead the development and execution of regulatory and clinical documents across oncology programs. You will provide strategic leadership, mentor authors, and collaborate with cross-functional teams to ensure high-quality, timely writing deliverables.

The role requires extensive experience in regulatory medical writing for oncology, plus strong leadership and project management skills to oversee internal teams and external vendors.

Qualifications

• Bachelor's degree required; advanced degree preferred
• Experience leading medical writing for regulatory submissions
• Strong knowledge of ICH guidelines and CTD structure
• Experience with oncology regulatory and clinical writing preferred

Responsibilities

• Plan, develop, author, review, and finalize regulatory and clinical documents (CSRs, IBs, protocols)
• Provide strategic medical writing leadership across cross-functional teams
• Interim and hands-on support for key medical writing deliverables
• Manage external vendors and ensure quality, timelines, and budgets
• Drive publication planning including abstracts, posters, and manuscripts

Skills

Leadership

Strategic writing

Regulatory knowledge

Medical writing

Education

Bachelor's degree

Advanced scientific degree (PhD/MD/PharmD)

Job description

AVEO Oncology in Boston seeks a Senior Director, Medical Writing to lead the development and execution of regulatory and clinical documents across oncology programs. You will provide strategic leadership, mentor authors, and collaborate with cross-functional teams to ensure high-quality, timely writing deliverables.

The role requires extensive experience in regulatory medical writing for oncology, plus strong leadership and project management skills to oversee internal teams and external vendors.